Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers
Phase 1
Completed
- Conditions
- Smoking Cessation
- Interventions
- Biological: SELA-070Biological: Saline
- Registration Number
- NCT03148925
- Lead Sponsor
- Selecta Biosciences, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Healthy Smokers
- Subjects must smoke a minimum of 10 but not more than 25 cigarettes per day for at least 3 months prior to enrollment
- Written informed consent
Primary
Exclusion Criteria
- Prior exposure to nicotine vaccines
- Female subjects of childbearing potential
- Current use of immunosuppressive agents
- History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)
- Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SELA-070 SELA-070 - Saline Saline -
- Primary Outcome Measures
Name Time Method Safety and tolerability of multiple subcutaneous injections of SELA-070 as assessed by frequency of vaccine related adverse events, graded by severity 21 weeks
- Secondary Outcome Measures
Name Time Method Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). 21 weeks
Trial Locations
- Locations (1)
SGS LSS Clinical Pharmacology Unit
🇧🇪Antwerpen, Belgium